Brazilian Regulator Extends COVID-19 Measures
Brazil’s medicines regulator is extending COVID-19 era resolutions designed to speed up its evaluation of clinical research in Brazil.
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The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.
EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'
The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.
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Drugs for treating Duchenne muscular dystrophy and amyotrophic lateral sclerosis are among the products that the European cross-country coalition BeNeLuxA thinks would be suitable for a joint health technology evaluation.